SAM #CDRH2026134634

FDA Procurement of Donor Animal Whole Blood for Medical Device Research

This procurement supports FDA medical device research requiring donor animal whole blood. - Government Buyer: - U.S. Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH), Office of Science and Engineering Laboratories (OSEL), Cardiovascular Program, Division of Applied Mechanics (DAM) - Products/Quantities Requested: - Donor, Sheep (Ovine) Whole Blood, ACD-A or Na Heparin, bleed and ship same day - Quantity: 15 liters - Donor, Porcine Whole Blood, ACD-A or Na Heparin, 500 mL, bleed and ship same day - Quantity: 500 mL - Donor, Bovine Whole Blood, ACD-A or Na Heparin (different donor per liter upon request), bleed and ship same day - Quantity: 110 liters - Box/Ice Charges per shipment (500 mL Liter): 30 shipments - Box/Ice Charges per shipment (2 x 1 Liter): 55 shipments - Unique/Notable Requirements: - Blood must be drawn and shipped on the same day - Acceptable anticoagulants: ACD-A or Na Heparin - Minimum delivery volumes and species-specific requirements - Veterinary oversight, AAALAC accreditation, and ISO 13485:2016 certification required - Strict labeling, quarantine protocol, and quality standards - No specific OEMs or vendors are named; opportunity is a total small business set-aside under NAICS 325414

Description

This is a synopsis of a procurement for commercial products prepared in accordance with the commercial acquisition procedures of RFO Part 12.

Solicitation No. 75F40126Q00362 was issued as a Request for Quotation (RFQ) for donor animal whole blood (bovine, ovine, and porcine) for the FDA Center for Devices and Radiological Health (CDRH), Office of Science and Engineering Laboratories (OSEL), Cardiovascular Program, Division of Applied Mechanics (DAM). The blood products support blood compatibility (hemocompatibility) testing and medical device research, including hemolysis- and thrombosis-related projects, as further described in Attachment 1 – Requirements Document.

All supplies shall meet the minimum requirements in Attachment 1 – Requirements Document, including species availability, minimum draw frequency, blood quality, minimum delivery volumes, anticoagulant type, labeling, quarantine protocol, veterinary oversight, AAALAC accreditation, and ISO 13485:2016 certification.

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